With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study.
Pavmed Inc. implanted its Portio system in three patients in a first-in-human (FIH) study of its intraosseous infusion system and successfully infused fluids in all patients without complications. The Portio system allows long-term direct access to bone marrow for delivery of fluids, medications and other substances in individuals with poor venous access, kidney dialysis or adverse reactions to anticoagulants.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
After a challenging 2021, nerve repair company Axogen Inc. is focusing on building clinical data to turn around its luck. The Alachua, Fla.-headquartered company reported disappointing fourth quarter results, with procedure volume negatively impacted due to COVID-19 and hospital staffing. The Nasdaq-listed company is anticipating results from a major phase III pivotal study comparing its flagship nerve graft product Avance to commercially available products in the second quarter of 2022.
Biological Dynamics Inc.’s Verita platform correctly identified 96% of patients with stage I pancreatic cancer, a study in Nature Communications Medicine demonstrated. The platform uses protein biomarkers present in extracellular vesicles and showed an overall 71% sensitivity and 99.5% specificity in pathologically confirmed stage I and II pancreatic, ovarian and bladder cancer.
Clinical researchers from Karl Landsteiner University in Krems, Austria, have been conducting a prospective study of a new diagnostic technique for bronchoscopy tissue sampling aimed at patients with unclear diffuse parenchymal disease. They have assessed morbidity and 30-day and 90-day mortality following transbronchial lung cryobiopsy. The team recently published their findings in Therapeutic Advances in Respiratory Disease.
At the AD/PD 2022 international conference on Alzheimer’s and Parkinson’s Diseases, AC Immune SA presented images showing its positron emission tomography (PET) tracer detecting pathological alpha-synuclein (a-syn) in human subjects’ brains. The abnormal accumulation of a-syn, a natively unfolded and soluble presynaptic protein, is a neuropathological feature of neurodegenerative disorders.
For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers.
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